WO2022172321A1 - 内視鏡 - Google Patents

内視鏡 Download PDF

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Publication number
WO2022172321A1
WO2022172321A1 PCT/JP2021/004757 JP2021004757W WO2022172321A1 WO 2022172321 A1 WO2022172321 A1 WO 2022172321A1 JP 2021004757 W JP2021004757 W JP 2021004757W WO 2022172321 A1 WO2022172321 A1 WO 2022172321A1
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WO
WIPO (PCT)
Prior art keywords
shaft
channel
camera
tip
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2021/004757
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English (en)
French (fr)
Japanese (ja)
Inventor
祐貴 児玉
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japan Lifeline Co Ltd
Original Assignee
Japan Lifeline Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japan Lifeline Co Ltd filed Critical Japan Lifeline Co Ltd
Priority to JP2022581044A priority Critical patent/JPWO2022172321A1/ja
Priority to CN202180093147.8A priority patent/CN116829045A/zh
Priority to PCT/JP2021/004757 priority patent/WO2022172321A1/ja
Priority to DE112021007058.4T priority patent/DE112021007058T5/de
Priority to TW110144545A priority patent/TW202233120A/zh
Publication of WO2022172321A1 publication Critical patent/WO2022172321A1/ja
Priority to US18/364,012 priority patent/US20230371799A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00066—Proximal part of endoscope body, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/0011—Manufacturing of endoscope parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/01—Guiding arrangements therefore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/042—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by a proximal camera, e.g. a CCD camera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A61B1/051—Details of CCD assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A61B1/053—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion being detachable

Definitions

  • the present invention relates to an endoscope, and more particularly to an endoscope equipped with a shaft to be inserted into the body, a handle for operation, and a camera.
  • an endoscope equipped with a shaft to be inserted into the body, a handle for operation, and a camera is known as a small endoscope used for diagnosis and treatment of bile ducts and pancreatic ducts through a duodenal endoscope. (See Patent Document 1 below).
  • a camera An optical assembly 40 is positioned to form a forceps channel (working channel 60) and a channel used for perfusion/aspiration etc. (additional channel 62).
  • the outer diameter of the shaft that constitutes the endoscope is about 5 to 12 Fr (1.67 to 4 mm), and the forceps channel (actuating channel 60) formed therein is used as a "recovery basket device or bioreactor.” "of sufficient diameter to accept actuators up to 4 Fr, such as an inspection forceps.”
  • Small endoscopes used for diagnostic treatment of bile ducts, pancreatic ducts, and the like have shafts with small outer diameters.
  • the outer diameter of the biological forceps that can be inserted into the forceps channel formed in the shaft is 4 Fr (1.33 mm) or less.
  • Such small-diameter biological forceps are much more expensive than general-purpose forceps with an outer diameter of about 1.75 to 1.85 mm. There is a problem that good clinical results cannot be obtained because sometimes sufficient tissue cannot be collected.
  • the small-diameter shaft that constitutes the endoscope has a channel for arranging a camera, a water supply channel, and a wire lumen for inserting an operation wire for deflecting the tip of the shaft. Therefore, the ratio of the resin constituting the shaft is low, and the shaft does not have sufficient rigidity, and kinks and the like are likely to occur at the tip flexible portion of the shaft. If a kink occurs in the tip flexible portion, there is a risk that the optical fiber arranged inside the shaft will break.
  • An object of the present invention is to provide a small-sized endoscope that can be used for diagnosis and treatment of bile ducts, pancreatic ducts, and the like, while allowing the use of general-purpose biological forceps.
  • Another object of the present invention is to provide an endoscope in which a kink is unlikely to occur at the distal end flexible portion of the shaft and an optical fiber constituting a light guide mechanism is not broken.
  • the endoscope of the present invention comprises a resin shaft having a distal flexible portion and having a camera channel and a forceps channel formed therein; a handle attached to the proximal end of the shaft; a camera having a camera head having an imaging element mounted thereon and a cable tube, and being detachably arranged with respect to the shaft and the handle by being inserted through the inside of the camera channel and the handle.
  • central axes of the camera channel and the forceps channel are located on the same plane including the central axis of the shaft;
  • the outer diameter (D) of the shaft is 2.8 to 4.1 mm;
  • the diameter (d1) of the camera channel is 0.75 to 1.2 mm; (D ⁇ d1) is 1.95 to 3.25 mm.
  • the shaft since the outer diameter (D) of the shaft is 2.8 to 4.1 mm, the shaft can be inserted into a bile duct, a pancreatic duct, or the like, and used for diagnosis and treatment in the duct. can be used. Further, since the difference (D ⁇ d1) between the outer diameter (D) of the shaft and the diameter (d1) of the camera channel is 1.95 to 3.25 mm, the forceps channel through which a commonly used biological forceps can be inserted. can be formed on the shaft.
  • the diameter (d1) of the camera channel is 0.75 to 1.1 mm, which is smaller than that of conventional endoscopes, it is possible to secure a certain proportion of the resin that constitutes the shaft. It is possible to prevent the kink from occurring in the tip flexible portion of the shaft.
  • the forceps channel has a diameter (d2) of 1.8 to 3.1 mm.
  • a general-purpose biological forceps having an outer diameter of about 1.75 mm can be inserted.
  • the forceps channel has a diameter (d2) of 1.9 to 2.1 mm.
  • a general-purpose biological forceps having an outer diameter of about 1.85 mm can be inserted.
  • the camera has a light guide mechanism including an optical fiber.
  • the endoscope having such a configuration it is not necessary to separately form a channel for arranging the optical fiber, and it is possible to sufficiently reduce the diameter of the shaft and the size of the device.
  • the camera that constitutes the endoscope of the present invention is detachably attached to the shaft (not fixed to the shaft), when the distal end flexible portion of the shaft is bent, the camera channel is bent. By moving the camera in the axial direction, the load on the optical fiber located inside the camera can be relieved.
  • the ratio of the total area of all channels or lumens including the camera channel and the forceps channel to the area of the shaft is 65% or less ( It is preferable that the ratio of the resin constituting the shaft is 35% or more).
  • the endoscope having such a configuration, it is possible to ensure the rigidity (bending rigidity) of the shaft to some extent, so that it is possible to effectively prevent kinks at the distal flexible portion.
  • the rigidity of the shaft at the semicircular portion where the camera (optical fiber) is located can be increased to prevent kinking, so that the distal end flexible portion of the shaft can be It is possible to reliably prevent disconnection of the optical fiber when it is bent.
  • the shaft has two water supply channels having a diameter (d3) of 0.4 to 1.0 mm and a diameter of 0.2 to 0.5 mm.
  • Four wire lumens having a diameter (d4) are formed, and an operation wire whose rear end can be pulled is extended in each of the wire lumens, and by pulling the rear end,
  • the tip of the shaft is configured to deflect.
  • the handle provided on the proximal end side of the shaft and provided with a rotation operation section; Disposed on the distal end side of the shaft, has substantially the same outer diameter as the shaft, communicates with each of the camera channel, the forceps channel and the water supply channel of the shaft and opens at the distal end surface thereof.
  • a resin tip in which a camera channel, a forceps channel and a water channel are formed; each of the camera channel, the forceps channel and the water channel of the shaft;
  • a main through hole formed so as to surround all of the communication paths, and a wire lumen formation position a metallic or ceramic intermediate member having four correspondingly formed secondary through-holes; Having a tip large-diameter portion embedded in the distal tip and having a diameter larger than the diameter of the secondary through-hole of the intermediate member, passing through each of the secondary through-holes to each of the wire lumens of the shaft It is preferable to have the four extending operating wires.
  • the intermediate member disposed between the resin shaft and the resin distal tip can reliably fix the distal end of the operation wire to the distal end of the shaft. can. That is, when the rear end of the operation wire is pulled, the large-diameter portion of the distal end is caught in the secondary through-hole of the intermediate member, so that the distal end of the operation wire can be restricted from moving in the proximal direction. As a result, the tip flexible portion of the shaft can be reliably bent.
  • the intermediate member disperses the pressing force in the proximal direction against the distal end surface of the shaft by the large-diameter tip portion (relieves the concentration of the pressing force). As a result, it is possible to more effectively prevent kink from occurring in the distal flexible portion even if the ratio of the resin constituting the shaft is not high.
  • the endoscope of the present invention is preferably used as a child endoscope inserted through the forceps lumen of a side scope such as a duodenal endoscope.
  • the endoscope of the present invention is preferably used for diagnosing and treating diseases in the bile duct or pancreatic duct.
  • the endoscope of the present invention although it is a small endoscope having a shaft with an outer diameter of 2.8 to 4.1 mm, it uses general-purpose biological forceps that could not be used with conventional small-diameter endoscopes. can do. In addition, kink is less likely to occur in the flexible portion at the distal end of the shaft, and breakage of the optical fiber constituting the light guide mechanism can be prevented.
  • FIG. 1 is an explanatory diagram showing the appearance of an embodiment of an endoscope of the present invention
  • FIG. 2 is a partially enlarged view (detailed view of part II) showing the distal end portion of the endoscope shown in FIG. 1
  • FIG. 3 is a view taken along line IIIA-IIIA of FIG. 2
  • FIG. 3 is a cross-sectional view (cross-sectional view of the shaft) along IIIB-IIIB in FIG. 2
  • FIG. 3 is a cross-sectional view taken along IIIC-IIIC in FIG. 2 (a cross-sectional view of the distal tip);
  • FIG. 3 is a cross-sectional view along IIID-IIID in FIG.
  • FIG. 2 is a perspective view showing the distal end portion (illustration of a camera is omitted) of the endoscope shown in FIG. 1;
  • FIG. 2 is a perspective view showing the distal end portion (illustration of a camera is omitted) of the endoscope shown in FIG. 1;
  • FIG. 1 is a perspective view showing the distal end portion (illustration of a camera is omitted) of the endoscope shown in FIG. 1;
  • FIG. 2 is a cross-sectional view showing a state in which a slide member of a camera connector that constitutes the endoscope shown in FIG. 1 is at a proximal end position;
  • FIG. 2 is a cross-sectional view showing a state in which a slide member of a camera connector that constitutes the endoscope shown in FIG. 1 is at a distal end position;
  • FIG. 2 is a perspective view showing a state in which the distal end of a camera that constitutes the endoscope shown in FIG. 1 is located at a first position on the proximal side with respect to the distal end surface of the distal tip.
  • FIG. 2 is a perspective view showing a state in which the distal end of a camera that constitutes the endoscope shown in FIG. 1 is located at a second position on the distal side with respect to the distal end face of the distal tip.
  • FIGS. 1-8 FIGS. 8A and 8B
  • This endoscope 100 has a distal flexible portion 10A, a camera channel 13, two water supply channels 141, 142 and a forceps channel 17, and four wire lumens 151, 152, 153, 154.
  • a formed resin shaft 10 a handle 20 disposed on the proximal end side of the shaft 10 and provided with a rotary operation section (an operation knob 25 and an operation knob 26); It is arranged on the distal side of the shaft 10, has the same outer diameter as the shaft 10, communicates with each of the camera channel 13, the water supply channels 141 and 142, and the forceps channel 17 of the shaft 10, and opens at the distal end surface 35 thereof.
  • a resin tip 30 in which a camera channel 33, water channels 341 and 342, and a forceps channel 37 are formed; It is arranged between the shaft 10 and the distal tip 30 and has a disc shape having the same outer diameter as the shaft 10.
  • a metallic intermediate member 40 having 4;
  • the leading end large diameter portions 511, 521, 531, 541 having diameters larger than the diameters of the secondary through holes 421, 422, 423, 424 of the intermediate member 40 are embedded in the tip 30, and the secondary through holes 421, 422 , 423, 424 to each of the wire lumens 151, 152, 153, 154 of the shaft 10, and the rear end of each of the wire lumens 151, 152, 153, 154 of the shaft 10 is connected to the rotary operation portion (the operation knob 25 or the operation knob 26) of the handle 20.
  • the central axes of the camera channel 13 and forceps channel 17 formed in the shaft 10 are located on the same plane including the central axis of the shaft 10, and the outer diameter (D) of the shaft 10 is 2.8 to 4.1 mm.
  • the diameter (d1) of the camera channel 13 is 0.75-1.1 mm
  • the difference (D ⁇ d1) between the outer diameter of the shaft 10 and the diameter of the camera channel is 1.95-3.25 mm.
  • This endoscope 100 includes a shaft 10 to be inserted into the body, a handle 20 arranged on the proximal side of the shaft 10, a distal tip 30 arranged on the distal side of the shaft 10, and the shaft 10 and the distal tip 30. It comprises an intermediate member 40 arranged between, operation wires 51, 52, 53, 54, and a camera 60. - ⁇
  • a camera channel 13 As shown in FIGS. 3B, 4A and 6A, a camera channel 13, water supply channels 141 and 142, and a forceps channel 17 are formed in the shaft 10 constituting the endoscope 100. As shown in FIGS. Further, the shaft 10 is formed with wire lumens 151, 152, 153, 154 through which the operation wires 51, 52, 53, 54 are inserted.
  • the length (effective length) of the shaft 10 is preferably 200 to 4800 mm, and a preferred example is 1900 mm.
  • the shaft 10 has a distal flexible portion 10A.
  • the "flexible tip portion” refers to the tip portion of the shaft that can be bent (bent) by pulling the rear end of the operation wire.
  • the length of the tip flexible portion 10A is preferably 5 to 200 mm, and a preferred example is 20 mm.
  • the outer diameter (D) of the shaft 10 is usually 2.8-4.1 mm, preferably 3.2-3.7 mm, and a preferred example is 3.6 mm.
  • Such a small-diameter shaft 10 can be inserted into a bile duct or a pancreatic duct for diagnostic treatment within the duct.
  • the diameter (d1) of the camera channel 13 is usually 0.75-1.2 mm, preferably 0.95-1.1 mm, and a preferred example is 1.05 mm.
  • the difference (D ⁇ d1) between the outer diameter (D) of the shaft 10 and the diameter (d1) of the camera channel is usually 1.95 to 3.25 mm, preferably 2.05 to 3.18 mm.
  • a typical example is 2.3 mm (3.5 mm-1.2 mm).
  • the difference (D-d1) between the outer diameter of the shaft (D) and the diameter of the camera channel (d1) is 1.9 Since the diameter is 5 to 3.25 mm, the diameter (d2) of the forceps channel 17 can be set to a size (1.8 mm or more) through which general-purpose biological forceps having an outer diameter of 1.75 mm or more can be inserted. can. If (D ⁇ d1) is less than 1.95 mm, it is impossible or extremely difficult to form a forceps channel through which a general-purpose biological forceps can be inserted. If (D ⁇ d1) exceeds 3.25 mm, it is impossible or extremely difficult to reduce the outer diameter of the shaft to 4.1 mm or less.
  • the camera channel has a diameter (d1) of 0.75 to 1.1 mm, which is smaller than that of conventional endoscopes, a certain proportion of the resin constituting the shaft 10 can be ensured. As a result, it is possible to prevent the tip flexible portion 10A of the shaft 10 from being kink. If (d1) is less than 0.75 mm, it is impossible or very difficult to insert the camera. If (d1) exceeds 1.1 mm, it is impossible or extremely difficult to make (D ⁇ d1) 3.25 mm or less.
  • the diameter (d2) of the forceps channel 17 is preferably 1.8-3.1 mm, more preferably 1.9-2.1 mm, and a preferred example is 2.0 mm. Since the diameter (d2) of the forceps channel 17 is 1.8 mm or more, it is possible to insert a general-purpose biological forceps having an outer diameter of about 1.75 mm, which cannot be inserted with a conventional endoscope. If the diameter (d2) of the forceps channel 17 is 1.9 mm or more, it is possible to insert general-purpose biological forceps having an outer diameter of about 1.85 mm.
  • general-purpose biological forceps By using such general-purpose biological forceps, a sufficient amount of tissue can be collected at the time of biopsy, and favorable clinical results can be obtained.
  • general-purpose biomedical forceps are significantly less expensive than forceps with an outer diameter of 4Fr (1.33 mm) or less that can be passed through a conventional endoscope.
  • the diameter (d3) of the water supply channels 141, 142 is preferably 0.4 to 1.0 mm, and a preferred example is 0.75 mm.
  • the diameter (d4) of the wire lumens 151, 152, 153, 154 is preferably 0.2-0.5 mm, and a preferred example is 0.33 mm.
  • the total area of the camera channel 13, forceps channel 17, water supply channels 141, 142, and wire lumens 151, 152, 153, 154 [ ⁇ (d1) 2 /4+ ⁇ (d2 ) 2 /4 + ⁇ (d3) 2 /2 + ⁇ (d4) 2 ] in the area of the shaft [ ⁇ (D) 2 /4] is 65% or less (ratio of resin constituting the shaft is 35% or more). more preferably 50 to 60%, and a preferred example is 55% [(1.1 2 ⁇ /4+2.0 2 ⁇ /4+0.75 2 ⁇ /2+0.33 2 ⁇ )/(3. 5 2 ⁇ /4)].
  • the shaft 10 is made of resin.
  • the resin material that constitutes the shaft 10 include nylon resin, polyether block amide (PEBAX) resin, polyurethane resin and polyolefin resin, among which PEBAX resin and polyurethane resin are preferred.
  • the hardness (Shore D hardness) of the constituent resin of the shaft 10 is preferably 90D or less.
  • the hardness of the resin constituting the other portion is set to 30D.
  • a handle 20 is arranged on the proximal end side of the shaft 10 .
  • a handle 20 that constitutes the endoscope 100 includes a grip 21 and two operation knobs 25 and 26 as rotary operation units.
  • the handle 20 is provided with a camera channel port 23 communicating with the camera channel 13 and a forceps channel port 27 communicating with the forceps channel 17 .
  • a distal tip 30 is arranged on the distal end side of the shaft 10 .
  • the distal tip 30 constituting the endoscope 100 is formed with a camera channel 33, water supply channels 341 and 342, and a forceps channel 37.
  • FIGS. 3A, 3C and 6B the distal tip 30 constituting the endoscope 100 is formed with a camera channel 33, water supply channels 341 and 342, and a forceps channel 37.
  • the camera channel 33 communicates with the camera channel 13 of the shaft 10 via a communication passage 43. As shown in FIG. The diameter of camera channel 33 is the same as the diameter of camera channel 13 communicating therewith.
  • the water channels 341 and 342 communicate with the water channels 141 and 142 of the shaft 10 via communication paths 441 and 442, respectively.
  • the water channels 341, 342 have the same diameter as the water channels 141, 142 communicating therewith.
  • Forceps channel 37 communicates with forceps channel 17 of shaft 10 via communication passage 47 .
  • the diameter of the forceps channel 37 is the same as the diameter of the forceps channel 17 communicating therewith.
  • the length of the distal tip 30 is preferably 1 to 30 mm, and a preferred example is 3 mm.
  • the distal tip 30 has the same outer diameter as the shaft 10 .
  • the tip 30 is made of resin.
  • the resin material forming the distal tip 30 the same resins as those exemplified as the resin forming the shaft 10 can be used. Among them, the PEBAX resin and the polyurethane resin are preferable.
  • the distal tip 30 is made of a low-hardness resin material so as not to damage body tissues.
  • the hardness (Shore D hardness) of the constituent resin of the distal tip 30 is preferably 72D or less, and a preferred example is 25D.
  • a disk-shaped intermediate member 40 is arranged between the shaft 10 and the distal tip 30 .
  • the intermediate member 40 constituting the endoscope 100 is a member for fixing the tip of each of the operation wires 51, 52, 53, 54 to the tip of the shaft 10 (preventing the tip from coming off when the rear end is pulled). .
  • the intermediate member 40 is formed with one main through-hole 41 surrounding all of the communication passage 43 and the communication passages 441, 442 and 47. As shown in FIGS. 3D and 6B, the intermediate member 40 is formed with one main through-hole 41 surrounding all of the communication passage 43 and the communication passages 441, 442 and 47. As shown in FIGS. 3D and 6B, the intermediate member 40 is formed with one main through-hole 41 surrounding all of the communication passage 43 and the communication passages 441, 442 and 47. As shown in FIGS.
  • the communication path 43 is a path (camera channel), and the diameter of the communicating path 43 is the same as that of the camera channel 13 and the camera channel 33 .
  • the communicating passages 441 and 442 are formed by the resin 130 of the shaft 10 and/or the distal tip 30 in order to communicate the respective water feeding channels 141 and 142 of the shaft 10 with the respective water feeding channels 341 and 342 of the distal tip 30. These are partitioned passages (water supply channels), and the diameters of the communication paths 441 and 442 are the same as the diameters of the water supply channels 141 and 142 and the water supply channels 341 and 342 .
  • the communication passage 47 is a passage (forceps channel) defined by the constituent resin 130 of the shaft 10 and/or the distal tip 30 in order to communicate the forceps channel 17 of the shaft 10 and the forceps channel 37 of the distal tip 30 .
  • the diameter of the communicating passage 47 is the same as the diameters of the forceps channel 17 and the forceps channel 37 .
  • the intermediate member 40 is formed with four secondary through holes 421 , 422 , 423 , 424 corresponding to the formation positions of the wire lumens 151 , 152 , 153 , 154 of the shaft 10 .
  • the secondary through holes 421 , 422 , 423 , 424 serve as passages for the operation wires 51 , 52 , 53 , 54 .
  • the secondary through-holes 421, 422, 423, 424 are circular holes, and their diameters are larger than the diameters of the operation wires 51, 52, 53, 54 to be inserted. , 521, 531, 541.
  • the diameter of the secondary through hole is preferably 0.13 to 2.5 mm, and a preferred example is 0.35 mm.
  • the thickness of the intermediate member 40 is preferably 0.05 to 3 mm, and a preferred example is 0.15 mm. If the thickness of the intermediate member 40 is too small, there is a risk that the intermediate member 40 will be damaged due to the mechanical impact that accompanies the pulling operation of the operating wires 51, 52, 53, . On the other hand, if the thickness is excessively large, the intermediate member 40 itself is difficult to bend, so there is a possibility that the tip flexible portion 10A may be difficult to bend.
  • the outer diameter of the intermediate member 40 is the same as the outer diameters of the shaft 10 and the distal tip 30, so that the outer peripheral surface of the shaft 10, the outer peripheral surface of the intermediate member 40, and the outer peripheral surface of the distal tip 30 are flush with each other. Intermediate member 40 does not protrude from between 10 and distal tip 30 to expose its edge, and such edge does not damage internal tissue.
  • the intermediate member 40 is made of metal or ceramics, preferably made of metal.
  • the metal material forming the intermediate member 40 include stainless copper, platinum, gold, copper, nickel, titanium, tantalum, etc. Among them, stainless copper is preferable.
  • the endoscope 100 of the present embodiment the area inside the main through hole 41 of the intermediate member 40 and outside each of the communicating paths 43, 441, 442, 47 (main through hole 41 excluding the communicating path) ), the shaft 10 and the distal tip 30 are directly joined (the resins constituting the two are welded together). Thereby, the intermediate member 40 is also fixed by the resin inside the main through hole 41 , and the intermediate member 40 is firmly fixed to the shaft 10 and the tip 30 . Moreover, since the shaft 10 and the distal tip 30 are directly joined, although partially, the fixing force of the distal tip 30 to the shaft 10 is sufficiently high.
  • (S) be the area of the region where the constituent resin of the shaft 10 and the tip 30 are directly bonded
  • (S 0 ) be the cross-sectional area of the shaft 10, then (S)/(S 0 ).
  • the value is preferably 0.1 or more, more preferably 0.3 to 0.6.
  • operation wires 51, 52, 53, and 54 extend through wire lumens 151, 152, 153, and 154 of shaft 10, respectively.
  • the distal ends of the operation wires 51, 52, 53, and 54 are distal large-diameter portions 511, 521, 531, and 541, respectively.
  • the tip large-diameter portions 511 , 521 , 531 , 541 are spherical or partially spherical with diameters larger than the diameters of the secondary through holes 421 , 422 , 423 , 424 of the intermediate member 40 . , 424 cannot be traversed.
  • the diameter of the tip large diameter portions 511, 521, 531, 541 is preferably 0.2 to 3.5 mm, and a preferred example is 0.4 mm.
  • the diameter of the operation wires 51, 52, 53, 54 (parts other than the tip large diameter portion) is preferably 0.1 to 2.0 mm, and a preferred example is 0.25 mm.
  • the operation wires 51 and 52 are held in a state in which their distal large-diameter portions 511 and 521 are embedded in the distal tip 30 , and the wire portions on the proximal side of the distal large-diameter portions 511 and 521 are attached to the intermediate member 40 . It extends to the wire lumens 151 and 152 of the shaft 10 through the secondary through holes 421 and 422 . Base ends of the operation wires 51 and 52 are fixed to the operation knob 25 of the handle 20, respectively.
  • the operation wire 51 moves in the wire lumen 151 in the proximal direction.
  • the tip large-diameter portion 511 is caught in the secondary through-hole 421 of the intermediate member 40 and restricted from moving in the proximal direction. and the distal end of the endoscope 100 (distal tip 30) deflects in the same direction.
  • the operation wire 52 moves in the wire lumen 152 in the proximal direction.
  • the tip large-diameter portion 521 is caught in the secondary through-hole 422 of the intermediate member 40 and is restricted from moving in the proximal direction, so that the tip flexible portion 10A of the shaft 10 moves in the direction indicated by the arrow A2 in FIG. 3A. and the distal end of the endoscope 100 (distal tip 30) deflects in the same direction.
  • the operation wires 53 and 54 are held in a state in which their distal large-diameter portions 531 and 541 are embedded in the distal tip 30 , and the wire portions on the proximal side of the distal large-diameter portions 531 and 541 are attached to the intermediate member 40 .
  • the wire lumens 153, 154 of the shaft 10 pass through the secondary through holes 423, 424. extends to Base ends of the operation wires 53 and 54 are fixed to the operation knob 26 of the handle 20, respectively.
  • the operation wire 53 moves in the wire lumen 153 in the proximal direction.
  • the tip large-diameter portion 531 is caught in the secondary through-hole 423 of the intermediate member 40 and restricted from moving in the proximal direction. and the distal end of the endoscope 100 (distal tip 30) deflects in the same direction.
  • the operation wire 54 moves in the wire lumen 154 in the proximal direction.
  • the tip large-diameter portion 541 is caught in the secondary through-hole 424 of the intermediate member 40 and restricted from moving in the proximal direction. and the distal end of the endoscope 100 (distal tip 30) deflects in the same direction.
  • the tip large-diameter portions 511 , 521 , 531 , 541 extend through the secondary through holes 421 , 422 , 422 , 422 formed in the intermediate member 40 . 423, 424 and the distal ends of the operation wires 51, 52, 53, 54 are fixed (retained) to the distal end of the shaft 10, thereby moving the distal flexible portion 10A of the shaft 10 in the desired direction. (directions indicated by arrows A1 to A4).
  • the distal end of the operating wire (tip large-diameter portion) is sufficiently pulled against the distal end of the shaft when the proximal end of the operating wire is pulled. It cannot be fixed (retained), and the distal large-diameter portion may move in the proximal direction while expanding the wire lumen, in which case the distal flexible portion cannot be deflected.
  • the material constituting the operation wires 51, 52, 53, 54 is not particularly limited, and the same material as the material constituting the operation wires used in conventionally known medical devices for tip deflection operation is used. be able to.
  • a camera 60 that constitutes the endoscope 100 is composed of a camera head 61 on which a CMOS image sensor 611 is mounted, and a cable tube 62 that includes a transmission cable for the CMOS image sensor 611 .
  • the camera 60 incorporates a plurality of (24 in the illustrated example) optical fibers 65 surrounding a CMOS image sensor 611 .
  • the diameter of the shaft 10 can be reduced and the size of the device can be sufficiently reduced.
  • the camera 60 constituting the endoscope 100 is detachably attached to the shaft 10 (not fixed to the shaft 10), when the distal end flexible portion 10A of the shaft 10 is bent, The axial movement of the camera 60 within the camera channel 13 relieves the load on the optical fiber 65 located inside the camera 60 .
  • the outer diameter of the camera head 61 is preferably 0.7 to 1.0 mm, and a preferred example is 1.0 mm.
  • the cable tube 62 has substantially the same outer diameter as the camera head 61 .
  • Camera 60 is positioned in camera channels (camera channel 13 and camera channel 33) of shaft 10 and distal tip 30, with a proximal portion of cable tube 62 extending out from camera channel port 23 of handle 20 and extending out of the cable tube.
  • the proximal end of is connected to a controller.
  • a camera connector 70 is attached to the cable tube 62 of the camera 60 .
  • This camera connector 70 is attached to the camera channel port 23 of the handle 20 when the cameras 60 are properly positioned in the camera channels 13 and 33 . That is, by attaching camera connector 70 to camera channel port 23 , camera 60 is properly positioned in camera channel 13 and camera channel 33 .
  • the mounting position of the camera connector 70 is 300 to 5000 mm from the tip of the camera 60, and a preferred example is 2100 mm from the tip of the camera 60.
  • the camera 60 can be separated from the handle 20 and the shaft 10 . That is, the camera connector 70 can be removed from the camera channel port 23 , and the cameras 60 arranged in the camera channels 13 and 33 can be removed together with the camera connector 70 from the camera channel port 23 of the handle 20 .
  • the once separated camera 60 is inserted from the camera channel port 23 of the handle 20 into the camera channel 13 of the shaft 10 inside the handle 20 with the camera head 61 at the front, and the camera connector 70 is inserted into the camera channel port 23.
  • the camera 60 can be reassembled as a component of the endoscope 100 .
  • the tip of the camera 60 arranged in the camera channel 13 and the camera channel 33 is positioned above the tip surface 35 of the tip tip 30 where the camera channel 33 opens.
  • a first position that is proximal (the distal position of the camera 60 as shown in FIG. 8A) and a second position that is distal to the distal surface 35 (the distal position of the camera 60 as shown in FIG. 8B).
  • a camera position adjustment mechanism for reciprocating the camera 60 with respect to the camera channel 13 and the camera channel 33 so as to be displaced between .
  • the distance from the first position to the second position (movement distance of the tip of the camera 60 by the position adjustment mechanism) is preferably 2 to 100 mm, and a preferred example is 30 mm. Further, the distance from the tip surface 35 of the tip 30 to the first position is preferably 1.5 to 20 mm, and the distance from the tip surface 35 to the second position is preferably 0.5 to 80 mm.
  • the camera position adjusting mechanism of the camera connector 70 is a mechanism that reciprocates the camera 60 using a feed screw. Specifically, it is attached to the camera channel port 23, and a guide groove (not shown) extending along the axial direction is formed on the inner peripheral surface, and a guide hole 713 extending along the axial direction is formed on the peripheral wall.
  • a connector case 71 Extending inside the connector case 71, a part of it extends to the base end side of the connector case 71, and a male screw part 722 is formed in the base end part, and the cable tube 62 of the camera 60 is inserted inside the connector case 71.
  • a rotary knob 73 located on the base end side of the connector case 71 and restricted from moving in the axial direction and having a female threaded portion 731 screwed to the male threaded portion 722 of the shaft portion 721 of the slide member 72, By rotating the rotary knob 73 in one direction and sliding the slide member 72 from the proximal position to the distal position, the distal end of the camera 60 is moved from the first position (the distal position of the camera 60 as shown in FIG. 8A). Camera 60 is moved to the second position (the distal end position of camera 60 as shown in FIG. 8B), rotated rotary knob 73 in the other direction, and slides slide member 72 from the distal position to the proximal position. from the second position to the first position.
  • proximal position is a position beyond which the slide member 72 cannot move proximally, as shown in FIG. 7A
  • distal position is, as shown in FIG. It is a position beyond which it cannot move to the tip side.
  • the camera position adjustment mechanism is composed of a connector case 71, a slide member 72, and a rotary knob 73.
  • the connector case 71 is a constituent member of the camera connector 70 that is attached to the camera channel port 23 via a port-side connector, which will be described later, and is made of a tubular body having an arched portion.
  • a guide groove extending along the axial direction is formed in the inner peripheral surface of the connector case 71, and a guide hole 713 extending along the axial direction is formed in the peripheral wall of the arch-shaped portion.
  • the slide member 72 is composed of a shaft portion 721 and a guide portion 723 integrally formed with the shaft portion 721 so as to surround the tip portion of the shaft portion 721 .
  • a shaft portion 721 of the slide member 72 extends inside the connector case 71 , and a portion of the shaft portion 721 extends from an opening formed in a proximal end surface 711 of the connector case 71 to the proximal side.
  • a male threaded portion 722 is formed at the base end portion of the shaft portion 721 .
  • the cable tube 62 of the camera 60 is inserted and fixed by adhesive.
  • the guide portion 723 of the slide member 72 has an arch-shaped portion matching the shape of the connector case 71 and is integrally formed with the shaft portion 721 so as to surround the tip portion of the shaft portion 721 .
  • the outer peripheral surface of the guide portion 723 is formed with a protruding portion that is guided by the guide groove of the connector case 71 .
  • a projecting portion 725 guided by the guide hole 713 of the connector case 71 is formed on the outer peripheral side of the arch-shaped portion of the guide portion 723 .
  • the rotary knob 73 is arranged on the proximal end side of the connector case 71 .
  • a female threaded portion 731 is formed on the inner peripheral side of the rotary knob 73 to be screwed onto the male threaded portion 722 of the shaft portion 721 of the slide member 72 .
  • the rotation knob 73 is restricted from moving in the axial direction with respect to the connector case 71 , and the slide member 72 slides with respect to the connector case 71 by rotating the rotation knob 73 . Further, by rotating the rotary knob 73 and sliding the slide member 72 , the cable tube 62 adhesively fixed inside the shaft portion 721 also moves in the axial direction with respect to the connector case 71 .
  • the rotary knob 73 is rotated in one direction to move the slide member 72 from the proximal position (the position shown in FIG. 7A) to the distal position (the position shown in FIG. 7B). ) to move the tip of the camera 60 from the first position (the tip position of the camera 60 as shown in FIG. 8A) to the second position (the tip position of the camera 60 as shown in FIG. 8B).
  • the rotary knob 73 By rotating the rotary knob 73 in the other direction to slide the slide member 72 from the distal position to the proximal position, the distal end of the camera 60 can be moved from the second position to the first position.
  • the shaft 10 can be inserted into a bile duct, a pancreatic duct, or the like to diagnose the inside of the duct. It can be used therapeutically. Further, since the difference (D ⁇ d1) between the outer diameter (D) of the shaft 10 and the diameter (d1) of the camera channel 13 is 1.95 to 3.25 mm, the diameter (d2) of the forceps channel 17 is It can be 1.8 mm or more, preferably 1.9 mm or more, through which a widely used biological forceps can be inserted.
  • the diameter (d1) of the camera channel 13 is 0.75 to 1.1 mm, which is smaller than that of a conventional endoscope, a certain proportion of the resin constituting the shaft 10 can be ensured. As a result, it is possible to prevent a kink from occurring in the tip flexible portion of the shaft.
  • the ratio of the total area of the camera channel 13, the forceps channel 17, the water supply channels 141, 142, and the wire lumens 151, 152, 153, 154 to the area of the shaft 10 is 65% or less.
  • the camera channel 13, the water supply channels 141 and 142, the wire lumens 151 and 153, and the forceps lumen 17 (protruding from the semicircular portion) are located in the semicircular portion on the side where the camera channel 13 is located.
  • the ratio of the total area of the semicircular portion to the area of the semicircular portion is 58% or less, so that the rigidity of the shaft 10 in the semicircular portion where the camera 60 (optical fiber 65) is located is increased
  • kink can be prevented, so that disconnection of the optical fiber 65 can be reliably prevented when the tip flexible portion 10A of the shaft 10 is bent.
  • the tips of the operation wires 51 , 52 , 53 , 54 can be reliably fixed to the tip of the shaft 10 by the metal intermediate member 40 arranged between the shaft 10 and the tip 30 . That is, when the rear ends of the operation wires 51, 52, 53, 54 are pulled, the tip large diameter portions 511, 521, 531, 541 are caught in the secondary through holes 421, 422, 423, 424 of the intermediate member 40. Therefore, the movement of the distal ends of the operation wires 51, 52, 53, 54 in the proximal direction can be restricted. As a result, the tip flexible portion 10A of the shaft 10 can be reliably bent in the desired direction.
  • the outer diameter of the intermediate member 40 is the same as the outer diameters of the shaft 10 and the tip 30, so that the outer peripheral surface of the shaft 10, the outer peripheral surface of the intermediate member 40, and the outer peripheral surface of the tip 30 are flush with each other. Therefore, the intermediate member 40 will not protrude from between the shaft 10 and the distal tip 30 and the edge thereof will not be exposed, and the edge of the intermediate member 40 will not damage the internal tissue.
  • the tip of the shaft 10 is flexible unlike conventional endoscopes in which the tip of the operation wire is fixed by a cylindrical metal member.
  • a smooth deflection operation can be performed by bending the entire area of the portion 10A.
  • the shaft 10 and the distal tip 30 are directly joined (the constituent resins of both are welded together), the intermediate member 40 is also fixed by the resin inside the main through hole 41, and the intermediate member 40 rotates around the axis of the shaft 10. There is no such thing as causing a positional deviation to occur.
  • the shaft 10 and the distal end tip 30 are directly joined inside the main through hole 41 of the intermediate member 40 and outside the communicating passages 43, 441, 442, 47.
  • the intermediate member 40 made of metal is interposed between the tip 30 and the tip 30, the tip 30 can be firmly fixed to the shaft 10, and the tip 30 falls off from the tip of the shaft 10. - ⁇ There is no such thing.
  • each of the distal end large diameter portions 511, 521, 531, 541 of the operating wires 51, 52, 53, 54 is embedded in the distal tip 30, when the operating wire 51 or 52 is pulled, this The distal end of the operating wire 52 or 51 facing the . does not move (extend) in the distal direction.
  • the camera 60 can be incorporated as a component of the endoscope 100 and reused.
  • the camera position adjustment mechanism reliably prevents the shaft 10 from being inserted into the delivery device or the body while the camera 60 is extended from the opening of the camera channel 33 on the distal end surface 35 of the distal tip 30. can do.
  • the tip position of the camera 60 with respect to the tip surface 35 of the tip tip 30 can be finely adjusted by a camera position adjustment mechanism that reciprocates the camera 60 using a feed screw.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Endoscopes (AREA)
  • Instruments For Viewing The Inside Of Hollow Bodies (AREA)
PCT/JP2021/004757 2021-02-09 2021-02-09 内視鏡 Ceased WO2022172321A1 (ja)

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JP2022581044A JPWO2022172321A1 (https=) 2021-02-09 2021-02-09
CN202180093147.8A CN116829045A (zh) 2021-02-09 2021-02-09 内窥镜
PCT/JP2021/004757 WO2022172321A1 (ja) 2021-02-09 2021-02-09 内視鏡
DE112021007058.4T DE112021007058T5 (de) 2021-02-09 2021-02-09 Endoskop
TW110144545A TW202233120A (zh) 2021-02-09 2021-11-30 內視鏡
US18/364,012 US20230371799A1 (en) 2021-02-09 2023-08-02 Endoscope

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RU2805798C1 (ru) * 2023-03-06 2023-10-24 Марат Касимович Давлиев Устройство для эндоскопии и способ его использования (варианты)

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JPH10276967A (ja) * 1997-04-09 1998-10-20 Olympus Optical Co Ltd 挿入用可撓体
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TW202233120A (zh) 2022-09-01

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